Founder, Chief Executive Officer
Founder and CEO of Lysogene, Ms. Karen Pignet-Aiach is also the mother of a child with MPS IIIA. She has a strong business background starting her career with Arthur Andersen specializing in audit and transaction services. Her entrepreneurial experience includes founding and running a financial business consultancy. From 2008 to 2009, Ms. Karen Pignet-Aiach served as a Member of the Pediatric Committee at the European Medicines Agency (EMA), established in accordance with the European Pediatric Regulation, as a patient representative. In 2008, she also served on the French Ethical Review Board CCPPRB at Ambroise Paré Hospital. Ms.Karen Pignet-Aiach has been involved with several not-for-profit organizations engaged in advocacy and research in the field of rare diseases such as Alliance Sanfilippo and Eurordis, where she served on the board as treasurer from 2010 to 2011. She is a founding executive member of the International Rare Diseases Research Consortium (IRDiRC).
Ms. Karen Pignet-Aiach graduated from the ESSEC Business School and majored in Economics from Institut d’Études Européennes of University Paris 8.
Chief Scientific Officer
Dr. Ralph Laufer is responsible for Lysogene's scientific activities. Before joining the company, Dr. Ralph Laufer was Senior Vice President at Teva Pharmaceutical Industries in Israel, where he managed small molecule discovery, nonclinical development and CMC, leading a team of over 400 scientists in 5 global sites. Prior to that, he was the Scientific Director of IRBM Science Park, a drug discovery CRO and biotech company in Rome, Italy. Previously, Dr Ralph Laufer was Head of Pharmacology at IRBM-Merck Research Laboratories Rome. He is the recipient of the American Chemical Society 2013 Heroes of Chemistry Award for his role in the discovery of IsentressTM (raltegravir), the first integrase inhibitor approved for use in HIV infected patients. Dr. Ralph Laufer originally trained as a molecular neurobiologist and his scientific achievements include the discovery of the tachykinin NK-3 receptor and the anti-obesity activity of ciliary neurotrophic factor. He is the author of about 90 scientific articles and inventor of about 20 patents.
Dr. Ralph Laufer obtained his PhD in Biochemistry (summa cum laude) and M.Sc. in Chemistry from the Hebrew University of Jerusalem. He conducted postdoctoral training at the Institut Pasteur in Paris.
Head of Regulatory affairs
Dr. Marie Deneux is in charge of defining and executing the regulatory strategy for drug development and coordinating marketing authorization applications. Prior to joining Lysogene, Dr. Marie Deneux was Senior Director, Regulatory Science, Drugs and Biologics at Voisin Consulting Life Sciences, where she assisted life sciences companies throughout the development of their products. Involved in the development of biotechnology products, new chemical entities, cell and gene therapy drugs and repurposed drugs, Dr. Marie Deneux has extensive experience in interactions with the European Medicines Agency (EMA), national European health authorities and the Food and Drug Administration (FDA).
Dr. Marie Deneux is a graduate engineer received an engineering degree from AgroParisTech (formerly INA-PG, Institut National Agronomique Paris-Grignon), completed by her Ph.D in cellular and molecular pharmacology at the French National Center for Scientific Research (CNRS).
Chief Technical Officer
Dr. Mark Plavsic is responsible for Lysogene’ s manufacturing strategy and CMC operational development. He has extensive technical experience across a diverse range of functions, proven knowledge of quality compliance and regulatory requirements and strong business and leadership skills gained from over 30 years of experience working in North America, Europe and Australasia. Prior to joining Lysogene, Dr. Mark Plavsic worked as Head of Process Development and Manufacturing at Torque Therapeutics, leading multiple functions including process and analytics development and ensuring quality controls and design across manufacturing. Prior to that, Dr. Mark Plavsic held multiple positions with Sanofi Genzyme, Astra Zeneca and Invitrogen Corporation.
Dr. Mark Plavsic received his Ph.D in Virology and Molecular Cell Biology, M.S. in Virology and Immunology, and Doctor of Veterinary Medicine degree from the University of Belgrade in Yugoslavia. He has a Board certification in Microbiology, subspecialty Virology from the American College of Veterinary Microbiologists.
Chief Medical Officer
Dr. Sophie Olivier is responsible for clinical development. A physician by background, Dr. Sophie Olivier has extensive clinical development experience in large and small pharma organizations and has overseen multiple regulatory interactions with both the FDA and the EMA, particularly in regard to pediatric regulation. Prior to joining Lysogene, Dr. Sophie Olivier was Chief Medical Officer at Genticel. Before joining Genticel, Dr. Sophie Olivier worked as Scientific Officer, Pediatric Team, at the European Medicines Agency in London. Previously, Dr. Sophie Olivier led clinical development in Women’s Health diseases at Wyeth Pharmaceutical (Philadelphia Area, US). With her extensive career as a senior manager in the industry, spanning from early development to ensuring market access, Dr. Sophie Olivier brings a rich breadth of experience across a variety of therapeutic areas to Lysogene.
Chief Patient Access Officer
Ms. Samantha Parker is Head of Lysogene’s Patient and Policy Affairs. Ms. Samantha Parker has specialised in rare disease research and public health since 2000. She has focused on expanding the expert disease community of healthcare professionals, patients, industry and regulators; building disease registries and natural history studies; developing consensus care guidelines; and developing strategies to improve the quality of diagnosis and patient care. Ms. Samantha Parker contributed, for several years, to the area of independent professional education in rare diseases. She is a member of the European Group of Experts on Rare Diseases (EGRD) and the International Rare Diseases Research Consortium (IRDiRC).
Ms. SamanthaParker has a B.A. (Hons) from Edinburgh University and an M.B.A (with distinction) in Life Sciences.